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Adult Anaplastic AstrocytomaPhase 1NCT01644955

Carboplatin in Treating Patients With Recurrent High-Grade Gliomas

A Phase 1 study testing carboplatin and Surgery in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Oligodendroglioma, run by James Elder at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is being done to evaluate the toxicity and safety of carboplatin administered by convection enhanced delivery into the tumor in patients with high grade glial neoplasms. This study is a dose escalating study, (the dose of the study drug is increased at set time points). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
carboplatin and Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
11 Jun 2012to 8 Dec 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have progressive disease for which craniotomy and tumor resection is recommended as treatment
  • Patients must sign a consent form indicating that they are aware of the investigational nature of the study; the informed consent form will indicate that the patient has been made aware of all other appropriate therapies
  • Patients with histologically confirmed grade III or IV astrocytoma, oligoastrocytoma, and oligodendroglioma who are at first or second recurrence
  • Patients require an initial diagnosis of a malignant glioma as outlined in the inclusion criteria which must be confirmed at the treating facility
  • Patients must have unequivocal evidence of tumor progression by magnetic resonance imaging (MRI) performed no longer than 28 days prior to study registration
  • Patients must have pathologically confirmed recurrence at the time of catheter placement
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  • Patients must be on a stable or decreasing dexamethasone dosage for at least 1 week prior to baseline MRI
  • Patients must have been treated previously with radiation therapy and treatment must have been completed at least 8 weeks prior to surgery for catheter implantation
  • Last dose of cytotoxic chemotherapy must have been at least 4 weeks (6 weeks for nitrosoureas) prior to catheter placement; patients are eligible if they received bevacizumab or other anti-vascular endothelial growth factor (VEGF) therapies, although the most recent dose must be at least 6 weeks prior to catheter placement
  • Patients previously treated with stereotactic radiosurgery, stereotactic radiotherapy, brachytherapy, Gliadel wafers or other intratumoral chemotherapy are eligible
  • Patients must have recovered from all prior therapy
  • Patients must have a life expectancy of >= 3 months and a Karnofsky performance status >= 60 Leukocytes >= 3,000/mcL Absolute neutrophil count >= 1,500/mcL Platelets >= 100,000/mcL Hemoglobin >= 9 g/dL Serum calcium =< 12.0 mg/dL Total serum bilirubin < institutional upper limit of normal (ULN) Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvate transaminase [SGPT]) =< 2.5 X institutional ULN Creatinine < 1.5 X institutional ULN
  • Women of child bearing years must have a negative pregnancy test (serum or urine) within 1 week of study entry; men and women of reproductive potential must agree to use an effective contraceptive method including one of the following: surgical sterilization (tubal ligation for women or vasectomy for men); approved hormonal contraceptives (such as birth control pills, Depo-Provera or Lupron Depro); barrier methods (such as condom or diaphragm) used with a spermicide cream or an intrauterine device (IUD)
  • Patient or designated individuals with durable medical power of attorney must give written informed consent prior to any study-specific procedures being implemented
  • Both men and women and members of all races and ethnic groups are eligible for this trial

Who cannot join

  • Patients with infratentorial, multifocal, or pathologically confirmed cerebrospinal fluid (CSF) disseminated tumor
  • Patients that have been treated with > 3 prior chemotherapy regimens
  • Pregnant or lactating women or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Patients who have a history of bleeding disorders including congenital or acquired coagulopathies
  • Known acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition or other acquired or congenital disorder of the immune system
  • Patients with unstable or serious concurrent illness including, but not limited to, ongoing or active infections requiring IV antibiotics or psychiatric illness/social situations that would limit compliance with study requirements are ineligible; (if patient has a stable chronic infection requiring oral antibiotics, the patient may be treated at the investigators discretion; however a clinical note must include the justification regarding the safety of treating the patient)
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  • Patients who have received any other investigational agent in a 28-day period prior to enrollment in this study
  • Patients whose tumors are located less than 2 cm from the ventricles
  • Patients taking greater than 12 mg daily of dexamethasone
  • Prior invasive malignancy that is not low-grade glioma, glioblastoma or gliosarcoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Intracerebral Convection Enhanced Delivery of Carboplatin for Treatment of Recurrent High-grade Gliomas

This study is being done to evaluate the toxicity and safety of carboplatin administered by convection enhanced delivery into the tumor in patients with high grade glial neoplasms. This study is a dose escalating study, (the dose of the study drug is increased at set time points). Carboplatin is in a class of drugs known as platinum-containing compounds; it slows or stops the growth of cancer cells in your body. Convection enhanced delivery involves placing one or more catheters into the brain and delivering chemotherapy through those catheters directly into the brain

Read the detailed description

PRIMARY OBJECTIVES:

  1. Establish the maximum tolerated dose and define the toxicity profile of carboplatin delivered intracerebrally via convection enhanced delivery (CED) for patients with high grade glial neoplasms.

SECONDARY OBJECTIVES:

  1. Examine the efficacy as defined by six-month progression free survival (PFS), median progression free survival, overall survival, and the radiographic response rate.

II. Evaluate the drug distribution.

OUTLINE: This is a phase I, dose-escalation study.

Patients undergo craniotomy and then receive carboplatin intracerebrally via convection-enhanced delivery (CED) over 72 hours.

Being tested
carboplatin, Surgery
Keywords
Gliomas, Carboplatin
Medical subject headings
Astrocytoma, Oligodendroglioma, Brain Neoplasms, Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

    Also called Carboplat, CBDCA, JM-8, Paraplat

    Carboplatin in a volume of 54 ml will be administered intracerebrally by convection enhanced delivery

  • SurgeryProcedure or surgery

    Also called craniotomy

    Patients will undergo surgery, which includes tumor resection and catheter placement, in the operating room.

Study groups in NCT01644955
Study groupRoleWhat they receive
Treatment (carboplatin)ExperimentalPatients will undergo surgery, which includes tumor resection and catheter placement, in the operating room and then receive carboplatin administered intracerebrally by convection enhanced delivery.
Receives: Drug: carboplatin; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Establish maximum tolerated dose and define toxicity profile

    The toxicity profile of carboplatin delivered intracerebrally via convection enhanced delivery (CED) for patients with high grade glial neoplasms. The maximum tolerated dose (MTD) of infused carboplatin may then be incorporated into future clinical studies.

    Measured: 72 hours after maximal medical therapy is initiated

Secondary outcomes (4)

  1. Six month progression free survival defined as the proportion of patients with stable disease at 6 months from surgery

    Measured: Time between surgery and earliest sign of disease progression or death, assessed up to 6 months

  2. Median progression free survival

    Measured: Time between surgery and earliest sign of disease progression or death, assessed up to 2 years

  3. Radiographic response rate

    Measured: Up to 2 years

  4. Overall survival

    Measured: Time from surgery until death, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2012 (estimated)
  2. Study start11 Jun 2012
  3. Primary completion8 Dec 2017
  4. Study completion8 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01644955
Sponsor's protocol ID
OSU-10151
Other IDs
NCI-2012-01057
Status last verified
Jun 2018
First submitted
17 Jul 2012
Last updated
2 Jul 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing carboplatin and Surgery in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Oligodendroglioma, run by James Elder at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish maximum tolerated dose and define toxicity profile (time frame: 72 hours after maximal medical therapy is initiated). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01644955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.

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